Catalog Number

4020

Brand Name

QuikClot

Version/Model Number

4020

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

Labeling does not contain MRI Safety Information

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

-

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

Yes

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

DEN160012,DEN160012

Product Code

POD

Product Code Name

Temporary, Internal Use Hemostatic

Public Device Record Key

a291dc5d-c99c-448d-82b8-223d2931e65c

Public Version Date

February 21, 2022

Public Version Number

6

DI Record Publish Date

September 20, 2017

Package DI Number

30841495140205

Quantity per Package

10

Contains DI Package

00841495140204

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CARTON